Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 076526

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FLUOROURACIL (FLUOROURACIL)
2%
Marketing Status: Prescription
Active Ingredient: FLUOROURACIL
Proprietary Name: FLUOROURACIL
Dosage Form; Route of Administration: SOLUTION; TOPICAL
Strength: 2%
Reference Listed Drug: No
Reference Standard: No
TE Code: AT
Application Number: A076526
Product Number: 001
Approval Date: Nov 5, 2003
Applicant Holder Full Name: TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
FLUOROURACIL (FLUOROURACIL)
5%
Marketing Status: Prescription
Active Ingredient: FLUOROURACIL
Proprietary Name: FLUOROURACIL
Dosage Form; Route of Administration: SOLUTION; TOPICAL
Strength: 5%
Reference Listed Drug: No
Reference Standard: No
TE Code: AT
Application Number: A076526
Product Number: 002
Approval Date: Nov 5, 2003
Applicant Holder Full Name: TARO PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

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